NCT01618266

Brief Summary

Epidemiological study of Ozurdex® in sites treating patients with retinal vein occlusion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
375

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 11, 2016

Completed
Last Updated

March 14, 2016

Status Verified

February 1, 2016

Enrollment Period

1.4 years

First QC Date

June 11, 2012

Results QC Date

January 13, 2016

Last Update Submit

February 16, 2016

Conditions

Macular EdemaRetinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

    BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.

    Baseline, Month 6

Secondary Outcomes (11)

  • Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO)

    Baseline, Month 6

  • Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO)

    Baseline, Month 6

  • Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients

    Baseline, Month 6

  • Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex®

    Baseline, Month 6

  • Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment

    Baseline, Month 6

  • +6 more secondary outcomes

Study Arms (1)

Ozurdex® (dexamethasone intravitreal implant)

dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.

Drug: dexamethasone intravitreal implant

Interventions

dexamethasone intravitreal implantDRUG

dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.

Also known as: Ozurdex®
Ozurdex® (dexamethasone intravitreal implant)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Macular Oedema due to Retinal Vein Occlusion

You may qualify if:

  • Macular oedema due to retinal vein occlusion

You may not qualify if:

  • Not living in metropolitan France

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Paris, France

Location

Related Publications (1)

  • Korobelnik JF, Kodjikian L, Delcourt C, Gualino V, Leaback R, Pinchinat S, Velard ME. Two-year, prospective, multicenter study of the use of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in the clinical setting in France. Graefes Arch Clin Exp Ophthalmol. 2016 Dec;254(12):2307-2318. doi: 10.1007/s00417-016-3394-y. Epub 2016 Jun 11.

    PMID: 27286894DERIVED

MeSH Terms

Conditions

Macular EdemaRetinal Vein Occlusion

Interventions

DexamethasoneCalcium Dobesilate

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Results Point of Contact

Title
Vice President Medical Affairs,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 13, 2012

Study Start

November 1, 2011

Primary Completion

April 1, 2013

Study Completion

October 1, 2014

Last Updated

March 14, 2016

Results First Posted

February 11, 2016

Record last verified: 2016-02

Locations

FR(1)